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Eye With Intacts With great pleasure, Solomon Eye Physicians and Surgeons in conjunction with Addition Technology announces FDA approval of larger size INTACS® corneal implants for the treatment of keratoconus.

INTACS® Corneal Implants are a medical device approved by the FDA for the correction of 1.00 to 3.00 diopters of myopia (nearsighted, shortsighted) and virtually no astigmatism in normal healthy corneas. Clear small semicircular plastic rings of various thickness, INTACS®, are inserted within the cornea at its outer edges. Insertion of these rings flatten the central area of the cornea and correct myopic refractive error. In lieu of the overwhelming response to Laser Assisted In-situ Keratomileusis (LASIK), INTACS® never became widely accepted, with the exception of the treatment of keratoconus.

Keratoconus is a disorder that involves a thinning and weakening of the central cornea. Due to a structural destabilization, the normally round shape of the cornea becomes distorted. A cone-like bulge develops, resulting in significant visual distortion. When placed in the peripheral cornea the central optical zone is flattened, and the foundation is strengthened.

To insert INTACS®, Dr. Solomon creates a single semicircular incision. The incision can be made with a mechanical separator, or with a femtosecond laser (INTRALASE), at a very precise depth 2/3rds of the way into the corneal bed. Dr. Jonathan D. Solomon belongs to a select group of surgeons worldwide certified to perform INTACS® surgery.

The placement of INTACS® inserts remodels and reinforces the cornea, eliminating some or all of the irregularities caused by keratoconus. Although glasses or contacts may still be required following treatment with INTACS®, coupled with other promising treatments, the procedure has been shown to reduce the progression of keratoconus. In doing so, INTACS® has been able to save patients from needing corneal transplantation.

Following the procedure, Dr. Solomon requires all patients to return for periodic monitoring and evaluation of the visual potential.

INTACS® have been approved for the treatment of keratoconus by the FDA under a Humanitarian Device Exemption (HDE) Humanitarian Use Devices (HUDs) are medical devices specially designated by the FDA for use in the treatment of fewer than 4000 patients per year with rare medical conditions.

The future holds a number of promising treatments currently in clinical trials. One such modality, Corneal Collagen Cross-Linking activation with riboflavin (CXL), is being studied in conjunction with Intacs, and in the short term has proven to slow the progression of ectasia. Although not FDA approved at this time, CXL addresses the idea of collagen rearrangement, or "sliding", as a root cause of progressive coning. It has been suggested that the slippage is facilitated by enzymatic tissue degradation. By exposing a cornea inundated with riboflavin to ultraviolet light, the collagen fiber is reinforced like concrete. Combined with Intacs, and the concrete is further supported with re-bar, thereby generating a tissue structure with considerably more rigidity.

INTACS® inserts are contraindicated for patients with collagen vascular, autoimmune or immunodeficiency diseases, who are pregnant or nursing, who have ocular disease, or are taking one of more of the following medications: isotretinoin (Accutane1), amiodarone (Cordarone2), sumatriptan (Imitrex3).

INTACS® are manufactured by Addition Technology.

If you have keratoconus and would like to schedule a consultation with Dr. Solomon, you may do so via email, or call for an appointment at 301.464.1885 or 301.982.4565

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